Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren; Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529451

CSPP100A2339

Details and patient eligibility

About

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

Enrollment: 1,613 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
• Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
• Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion criteria

• Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
• History or evidence of a secondary form of hypertension.
• History of transient ischemic cerebral attack within 12 months of visit 1.
• Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
• Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
• Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,613 participants in 4 patient groups

Aliskiren 300 mg

Experimental group

Description:

Aliskiren 300 mg once daily

Treatment:

Drug: Aliskiren

Aliskiren 150 mg

Experimental group

Description:

Aliskiren 150 mg once daily

Treatment:

Drug: Aliskiren

Aliskiren 75 mg

Experimental group

Description:

Aliskiren 75 mg once daily

Treatment:

Drug: Aliskiren

Ramipril 5 mg

Active Comparator group

Description:

Ramipril 5 mg once daily

Treatment:

Drug: Ramipril